of the Endocrinology Subcommittee of PTAC teleconference held at PHARMAC on 17 May 2018 1 Denosumab for treatment of osteoporosis in men Application 1.1 The Subcommittee considered a paper from PHARMAC staff on denosumab for the treatment of osteoporosis in men. Recommendation 1.2 The Subcommittee...

(Underlying cause - Osteoporosis) or has had a Special Authority approval for alendronate (Underlying cause - Osteoporosis) prior to 1 February 2019 Note: a) BMD (including BMD used to derive T-Score) must be measured using dual-energy x-ray absorptiometry (DXA). Quantitative ultrasound and quantitative...

2003 Meeting of the Pharmacology and Therapeutics Advisory Committee Record of the 18 November 2002 meeting of the Osteoporosis Sub-committee The Committee reviewed the record of the 18 November 2002 Osteoporosis Sub-committee meeting as follows: Raloxifene The Committee agreed with the recommendations...

Osteoporosis Subcommittee of PTAC meeting held 31 March 2009 (minutes for web publishing) Osteoporosis Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and PTAC Subcommittees 2008: Note that this document...

osteoporosis ❍ and The patient is female and postmenopausal ❍ or ❍ The patient is male or non-binary and History of one significant osteoporotic fracture demonstrated radiologically and documented bone mineral density (BMD) greater than or ❍equal to 2.5 standard deviations below the mean normal value...

of osteoporotic fractures. We believe that the current access criteria for alendronate in the treatment of osteoporosis now has the potential to confer considerable population health gains, and that past criteria targeted alendronate so that other areas of health gain were not jeopardised. Discussions...

measurements (see Notes) or ❑ Patient has had a Special Authority approval for zoledronic acid (Underlying cause – Osteoporosis) or has had a Special Authority approval for alendronate (Underlying cause - Osteoporosis) prior to 1 February 2019 Note: a) BMD (including BMD used to derive T-Score) must...

to support the clinical management of osteoporosis rather than ‘transported’ into other areas. The funding of risedronate was welcomed, however, some had concerns about it being open listed and there being consequent inappropriate use of risedronate. One responder was concerned that the proposal...

unless notified. Prerequisites (tick boxes where appropriate) The patient has severe, established osteoporosis ❑ and The patient is female and postmenopausal ❑ or ❑ The patient is male or non-binary and History of one significant osteoporotic fracture demonstrated radiologically and documented bone...

Osteoporosis Subcommittee of PTAC meeting held 25 August 2009 (minutes for web publishing) Osteoporosis Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and PTAC Subcommittees 2008. Note that this document...

and The patient will not be prescribed more than 5 mg of zoledronic acid in the 12-month approval period ❑ INITIAL APPLICATION - Underlying cause - Osteoporosis Applications from any relevant practitioner. Approvals valid without further renewal unless notified. Prerequisites (tick boxes where...

or ❍ Osteoporosis where there is significant risk of fracture or ❍ Severe acne following treatment with conventional corticosteroid therapy or ❍ History of severe psychiatric problems associated with corticosteroid treatment Form RS1723 June 2020 PRESCRIBER Name...

(tick box where appropriate) Prescribed by, or recommended by any specialist, or in accordance with a protocol or guideline that has been endorsed by the DHB Hospital. ❍ and Patient has been diagnosed with an inherited bone fragility disorder (e.g. osteogenesis imperfecta) ❍ INITIATION - Osteoporosis...

should no longer be used to treat osteoporosis due to an unfavourable risk: benefit profile. In particular, the PRAC highlighted the cardiovascular risks (including heart attacks and blood clots) as well as serious skin reactions, disturbances in consciousness, seizures, liver inflammation and reduced...

considered an application by Eli Lilly for the listing of raloxifene on the Pharmaceutical Schedule under the same Special Authority criteria as applied to alendronate (without the indication of glucocorticosteroid-induced osteoporosis). The Committee noted that the Osteoporosis Sub-committee had...

or ❑ Osteoporosis where there is significant risk of fracture or ❑ Severe acne following treatment with conventional corticosteroid therapy or ❑ History of severe psychiatric problems associated with corticosteroid treatment Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker...

valid without further renewal unless notified for applications meeting the following criteria: All of the following: 1 The patient is a postmenopausal woman with severe, established osteoporosis; and 2 Any of the following: 2.1 History of one significant osteoporotic fracture demonstrated...

, established osteoporosis ❑ and The patient has a documented T-score less than or equal to -3.0 (see Notes) ❑ and The patient has had two or more fractures due to minimal trauma ❑ and ❑ The patient has experienced at least one symptomatic new fracture after at least 12 months’ continuous therapy...